To Evaluate the Safety and Performance of the ProstaCare Water Electrolysis System in Relieving Symptoms of BPH.

Not Applicable

Terminated

Conditions: Benign Prostatic Hyperplasia

Interventions: Device: prostaFix System

Registration Number: NCT02962674

Lead Sponsor: ProstaCare Singapore Pte. Ltd.

Brief Summary: The purpose of this study is to evaluate the safety and performance of the ProstaCare System in relieving symptoms of urinary outflow obstruction secondary to benign prostatic hyperplasia.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: Male

Target Recruitment: 49

Inclusion Criteria

45 years of age or older with a diagnosis of BPH,
International Prostate Symptom Score (IPSS) of 12 or greater,
Prostate volume between 25 cm3 and 55 cm3,
Uroflow with peak flow rate (Qmax) no greater than 13 ml/sec with a corresponding voided volume of at least 100 ml and a post void residual (PVR) of 250 ml or less.
Prostate length, width and height must be at least 3.2 cm, 3.5 cm and 2.5 cm, respectively

Key

Exclusion Criteria

Obstruction due to an enlarged middle lobe, central gland or significant transverse asymmetry,
Subjects on 5 alpha reductase inhibitors (5-ARI) (inclusion only if washed out prior to treatment),
Subjects on alpha blockers (inclusion only if washed-out before treatment),
Active urinary tract infection at time of treatment,
Interest in maintaining fertility,
Past history of urologic surgery or minimally invasive treatment for BPH,
History of or current medical conditions contraindicating elective urological procedures.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	prostaFix System	-

Primary Outcome Measures

Name	Time	Method
Mean International Prostate Symptom Score (IPSS) at 3 Months Follow-up Visit	3 months after treatment	The primary effectiveness objective was to demonstrate that mean IPSS improvement (Δ IPSS) following treatment with the prostaFix System exceeded 6.5 points with 95% confidence 3 months after treatment. The International Prostate Symptom Score (IPSS) is a validated questionnaire used to assess baseline and post treatment BPH symptoms. It is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the subject to choose one out of six answers indicating increasing severity of that particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic): Mild (symptom score less than or equal to 7), Moderate (symptom score range 8-19) and Severe (symptom score range 20-35). Improvement in BPH symptoms is seen as a decrease in IPSS.
Number of Participants With Serious Adverse Events (SAEs)	3 months after treatment	The primary safety objective of this study was to estimate the proportion of subjects affected by serious adverse events (SAEs) associated with the use of the device. This objective was addressed through recording all adverse events (AEs) observed or reported during the course of the study.

Secondary Outcome Measures

Name	Time	Method
Mean Change in QOL From Baseline	Baseline and 12 months from treatment	Question eight of the IPSS questionnaire refers to the subject's perceived quality of life (QOL). The International Scientific Committee (SCI), under the patronage of the World Health Organization (WHO) and the International Union Against Cancer (UICC), recommends the use of only a single question to assess the quality of life. The answers to this question range from "delighted" to "terrible" or 0 to 6.
Mean Change in Post Void Residual (PVR) From Baseline	Baseline and 12 months from treatment	The Post Void Residual (PVR) is an indicator of urine remaining in the bladder after voiding. A healthy bladder should be fairly empty following urination. A volume \< 50 mL is normal; \< 100 mL is usually acceptable in patients \> 65 years old. The higher the PVR, the more urine is left in the bladder and this can be seen as a sign of increased obstruction of the urethra.
Mean Change in Peak Flow Rate (Qmax) From Baseline	Baseline and 12 months from treatment	Uroflowmetry measures the flow of urine. It tracks how fast urine flows (peak flow rate - Qmax), how much flows out, and how long it takes. It's a diagnostic test to assess how well the urinary tract functions. Uroflowmetry is used in BPH subjects to help the doctors determine how well the subject's urinary tract is doing and the severity of obstruction caused by the prostate. The higher the Qmax is, the less obstructed the urethra.
Mean Change in MSHQ-EjD From Baseline	Baseline and 12 months from treatment	The MSHQ-EjD Short Form (Male Sexual Health Questionnaire - Ejaculatory Disfunction) is composed of three questions that rate ejaculatory function in men. A fourth question measures the MSHQ-EjD Bother, this asks the subject if he is bothered by his level of ejaculatory function. MSHQ-EjD total score ranges from 1 to 15 with a higher score indicating better sexual functioning. MSHQ-EjD bother score ranges from 0 to 5 with a higher score indicating greater bother. An increase in the MSHQ-EjD Total Score indicates better ejaculation and a decrease in the MSHQ-EjD Bother Score means that the subject is less bothered by his ejaculatory function. Due to the sensitive nature of the questions, this questionnaire is voluntary and not all subjects completed it at baseline. Some subjects completed at baseline but decided not to complete at certain follow-up visits which explains the different number of participants during various analysis time frames.
MRI Necrosis Volume	3 months after treatment	The prostaFix System uses pH shifts induced by water electrolysis to induce necrosis in the hyperplastic prostate tissue. The induced necrosis within the borders of the prostate result in a pressure reduction and thereby relieve the symptoms of BPH. This necrosis that resulted from the procedure eventually heals and necrosis volume should reduce overtime. Per protocol, only the first 10-15 subjects would have MRI studies at done to assess subject safety and treatment effect. then MRI was optional. A total of 14 subjects actually had an MRI and the results are reported for those subjects.
Change in IIEF Score From Baseline	Baseline and 3 months after treatment	The IIEF (International Index of Erectile Function) provides a broad measure of sexual function; an increase in score indicates an improvement in sexual function. This questionnaire consists of five questions that asks the subject of any erection problems that have impacted his sexual life over the past 4 weeks or since the last study visit, whichever is shorter. IIEF total score ranges from 0 to 25 with a higher score indicating better sexual functioning and an increase in score indicates an improvement in sexual function. Due to the sensitive nature of the questions, this questionnaire is voluntary and not all subjects completed it at baseline. Some subjects completed at baseline but decided not to complete at certain follow-up visits which explains the different number of participants during various analysis time frames.
Mean Change in IIEF From Baseline	Baseline and 12 months from treatment	The IIEF (International Index of Erectile Function) provides a broad measure of sexual function; an increase in score indicates an improvement in sexual function. This questionnaire consists of five questions that asks the subject of any erection problems that have impacted his sexual life over the past 4 weeks or since the last study visit, whichever is shorter. IIEF total score ranges from 0 to 25 with a higher score indicating better sexual functioning and an increase in score indicates an improvement in sexual function. Due to the sensitive nature of the questions, this questionnaire is voluntary and not all subjects completed it at baseline. Some subjects completed at baseline but decided not to complete at certain follow-up visits which explains the different number of participants during various analysis time frames.
Mean Change in MSHQ-EjD Score From Baseline	Baseline and 3 months after treatment	The MSHQ-EjD Short Form (Male Sexual Health Questionnaire - Ejaculatory Disfunction) is composed of three questions that rate ejaculatory function in men. A fourth question measures the MSHQ-EjD Bother, this asks the subject if he is bothered by his level of ejaculatory function. MSHQ-EjD total score ranges from 1 to 15 with a higher score indicating better sexual functioning. MSHQ-EjD bother score ranges from 0 to 5 with a higher score indicating greater bother. An increase in the MSHQ-EjD Total Score indicates better ejaculation and a decrease in the MSHQ-EjD Bother Score means that the subject is less bothered by his ejaculatory function. Due to the sensitive nature of the questions, this questionnaire is voluntary and not all subjects completed it at baseline. Some subjects completed at baseline but decided not to complete at certain follow-up visits which explains the different number of participants during various analysis time frames.
Mean Change in IPSS From Baseline	Baseline and 12 months from treatment	The International Prostate Symptom Score (IPSS) is a validated questionnaire used to assess baseline and post treatment BPH symptoms. It is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the subject to choose one out of six answers indicating increasing severity of that particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic): Mild (symptom score less than or equal to 7), Moderate (symptom score range 8-19) and Severe (symptom score range 20-35). Improvement in BPH symptoms is seen as a decrease in IPSS.

Trial Locations

Locations (3): Urology Bay of Plenty (BOP)
🇳🇿
Tauranga, New Zealand
Singapore General Hospital
🇸🇬
Singapore, Singapore
National University Hospital
🇸🇬
Singapore, Singapore